Outcome of Two Protocols in Poor Responders in Assisted Reproductive Technology (ART) Cycle

Royan Institute

Status and phase: Completed; Phase 3

Conditions: Infertility

Treatments: Drug: Microdose GnRh; Drug: Flare up

Study type: Interventional

Funder types: Other

Identifiers

NCT01006954

Royan-Emb-003

Details and patient eligibility

About

About 9 to 24 % of women undergoing in vitro fertilization (IVF) treatment respond poorly to the usual gonadotrophin stimulation protocol applied. Several induction ovulation treatments have been suggested for increasing pregnancy rate. In this study, the investigators will compare the outcome of Microflare protocol and Flare up regimen in poor responders.

Full description

In this randomized clinical trial study, a total of 200 infertile women with poor ovarian response who undergo IVF / ICSI treatment cycle at Royan Institute will enroll in this study and will randomly be divided into two groups of 100 patients. This study has been approved by Royan ethics committee and written consent will be obtained from each patient.

The patients will be randomized to one of two groups of Flare Up or Microdose GnRh agonist flare up.

Luteinizing Hormone (LH), Follicle Stimulating Hormone (FSH), Estradiol, will be evaluated on day 2 or 3 and when follicle size become >14.

2 weeks after embryo transfer, the patients will be tested for serum β-hCG for assessing the pregnancy. The clinical pregnancy will be clarified by the number of women with gestational sacs on transvaginal sonography at 4-6 weeks of gestation. In the calculation of implantation, the number of gestational sacs will be considered.

Enrollment: 200 patients

Sex: Female

Ages: 30 to 42 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

Poor responders (Presence of at least two of following items is necessary for inclusion to the study)

• History of Cycle Cancellation
• History of oocyte number 3 (in previous cycle)
• History of Number of antral follicle < 5 in previous cycle
• Age≥38
• FSH>12 on day 2 or 3
• Ovarian Volume 3 cm3

Exclusion criteria

• Male factor (azospermi)
• Myoma ≥6cm
• One way ovary
• Tumor or cyst >13mm
• Age >42

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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200 participants in 2 patient groups

Flare Up

Active Comparator group

Description:

Flare up protocol in poor responders for IVF/ICSI

Treatment:

Drug: Flare up

Microdose GnRh

Experimental group

Description:

Microflare protocol in poor responders for IVF/ICSI

Treatment:

Drug: Microdose GnRh